Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study

Purpose

The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely.

Conditions

  • Anxiety Disorder of Childhood
  • Fear
  • Shyness

Eligibility

Eligible Ages
Between 21 Months and 47 Months
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • The child scores >1 Standard Deviation (SD) above reported means for the Fear or Shyness scales on the Early Childhood Behavior Questionnaire (ECBQ) (if child is 21-35 months) or the child scores >1SD above reported means for the Total Anxiety, Generalized Anxiety, Social Anxiety, Physical Injury Fears, or Separation Anxiety scales on the Preschool Anxiety Scale (PAS) (if child is 36-47 months) as completed by a parent - The parents are able to speak, understand, and read English - The child must have a working knowledge of English.

Exclusion Criteria

  • Autism Spectrum Disorder (ASD) or global developmental delay in the child - The child has disruptive behavior so severe as to interfere with participation in intervention sessions - The child has a different primary disorder for which CBT for anxiety is inappropriate (e.g. severe depression, depression in the mother, significant medical disorder).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active Treatment 		Up to 12 sessions of Parent-Child CBT using an adaptation of the Being Brave protocol
  • Behavioral: Being Brave
    Up to 12 weekly sessions
Active Comparator
Parent Education 		Parents receive educational materials about how to help young children overcome shyness and anxiety
  • Other: Parent Education
    Parents receive educational materials about helping children overcome shyness and fear
No Intervention
Monitoring

More Details

Status
Active, not recruiting
Sponsor
Massachusetts General Hospital

Study Contact